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News
FDA inspection readiness: How to prepare for surveillance and pre-approval inspections
1+ hour, 20+ min ago (450+ words) Manufacturing Chemist This video is for pharma, biotech, and quality leaders responsible for FDA inspection readiness. Learn how to prepare for surveillance and pre-approval inspections, build a culture of continuous compliance, and reduce regulatory risk. In this discussion, NSF breaks…...
Simris Group appoints biotechnology expert Dr. Tiffany J. Vora as strategic advisor
16+ hour, 26+ min ago (363+ words) Manufacturing Chemist Dr. Vora is a biotechnology scientist, entrepreneur, educator and advisor with experience across molecular biology, genomics, biotechnology innovation and drug discovery. Through her work with technology companies, startups, scientific organizations and the broader innovation ecosystem, she has developed…...
Gerresheimer starts operations at new plant in Zhenjiang Dagang, China
16+ hour, 46+ min ago (523+ words) Manufacturing Chemist Gerresheimer, an innovative system and solution provider and global partner to the pharma, biotech, and cosmetic industries, has started operations at a new plant in Zhenjiang Dagang, China, for the production of glass primary pharmaceutical packaging. After approximately…...
AstraZeneca’s Trixeo recommended for EU approval in asthma, expanding triple therapy use
1+ day, 56+ min ago (440+ words) The recommendation is based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AZ's single-inhaler fixed-dose triple therapy compared with inhaled dual therapy Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and…...
Mechitronic acquires Lambert to strengthen pharma and medtech assembly platform
1+ day, 18+ hour ago (474+ words) The €20m deal adds Lambert's 50-year complex assembly and filling automation expertise in Tadcaster to Mechitronic's 15-brand network, strengthening the group's UK pharma presence as it targets €285m aggregate revenue These include web converting and specialist filling and dosing applications, serving the…...
FDA panel backs six peptides for pharmacy compounding
2+ day, 20+ hour ago (395+ words) FDA advisers have recommended allowing six peptides onto the US 503A compounding list, potentially opening a new route to regulated supply — despite concerns around safety, efficacy and manufacturing quality FDA advisers have recommended that six controversial peptides be added to the…...
What’s changing at the FDA? Dr. Julia Marré explains the new U.S. regulatory landscape
3+ day, 21+ min ago (347+ words) Manufacturing Chemist Brian Cleary, Global Director of Marketing at NSF Life Sciences meets with his colleague Dr. Julia Marré to discuss the most significant changes happening right now across the FDA and the U.S. regulatory landscape. From shifting expectations…...
MULTIVAC selects Siemens Teamcenter for digital manufacturing transformation
5+ day, 17+ hour ago (364+ words) Packaging and processing equipment manufacturer MULTIVAC is adopting Siemens Teamcenter as its strategic PLM backbone to connect engineering and manufacturing and prepare for AI-enabled engineering MULTIVAC has announced that it has selected Siemens’ Teamcenter software as its strategic product lifecycle…...
The growing importance of cleaning validation in ADC biologics manufacturing
6+ day, 1+ hour ago (124+ words) Antibody–drug conjugates (ADCs) have emerged as one of the most sophisticated therapeutic modalities in modern biologics manufacturing. By combining the targeting precision of monoclonal antibodies with highly potent cytotoxic payloads, ADCs enable the direct delivery of treatments to diseased…...
Brenntag launches BYPHAR biopharma raw material portfolio spanning R&D through commercial GMP manufacture
6+ day, 18+ hour ago (184+ words) The three-tier range — covering non-GMP research materials through LBLE critical-grade excipients — consolidates regulatory documentation, global supply reliability and technical support for mAbs, CGT, ADCs and nucleic acid production under one brand BYPHAR GMP samples for all products are now available…...